NCT00170833

Brief Summary

This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

September 9, 2005

Last Update Submit

November 1, 2011

Conditions

Renal Transplantation

Keywords

Renal/Kidney, transplantation, everolimus, calcineurin sparing

Outcome Measures

Primary Outcomes (1)

  • renal function as measured by serum creatinine at 6 months post-transplant

Secondary Outcomes (5)

  • Renal function as measured by calculated creatinine clearance and calculated glomerular filtration rate at 6 months

  • Occurrence of biopsy-proven acute rejection at 6 months post-transplant

  • Combined and individual incidence of biopsy-proven acute rejection episodes, graft loss, and death at 6 months

  • Incidence of adverse events and serious adverse events

  • Incidence of New Onset Diabetes post-transplant at 3 and 6 months

Interventions

EverolimusDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients between 18 and 65 years of age
  • Male or female patients who are primary cadaveric, living unrelated or non-HLA identical living related donor renal transplant recipients
  • The renal cold ischemic time (CIT) must be \< 30 hours
  • The age of the donor must be between 10 and 59 years and not meet UNOS expanded donor criteria

You may not qualify if:

  • Patients meeting any of the following criteria at baseline will be excluded from study participation.
  • Patients who have previously received an organ transplant
  • Patients who are recipients of a multiple organ transplants
  • Recipients of non heart-beating donor organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M; CRADUS09 Study Group. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation. 2008 Mar 27;85(6):821-6. doi: 10.1097/TP.0b013e318166927b.

    PMID: 18360262DERIVED

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2003

Primary Completion

November 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11